Santarus Announces Presentation of UCERIS Phase III Extended Use



Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. According to the Crohn’s & Colitis Foundation of America, IBD affects an estimated 1.4 million Americans.

Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to aminosalicylate (5-ASA) drugs. Patients refractive to treatment with 5-ASA drugs typically receive a course of an oral, systemically absorbed corticosteroid, the success of which may be limited by significant side effects. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

Santarus Presentation of UCERIS Extended Use Data at Meeting May 18, 2012 – Santarus, Inc. (NASDAQ: SNTS) today announced that safety and efficacy data from a Phase III, double-blind, multicenter, -controlled 12 month extended use study with the ™ (budesonide) 6 mg tablets (previously referred to as budesonide MMX®) will be featured in four poster presentations at the Digestive Disease Week (DDW®) Meeting being held at the on May 19 – 22, 2012.

A total of 123 patients were enrolled in the extended use study, which was undertaken to evaluate the long-term safety and tolerability of UCERIS 6 mg. The extended use study also explored the efficacy of UCERIS 6 mg in the maintenance of of ulcerative colitis compared to placebo, but the study was not powered to show statistical significance.

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